On November 29, 2022 Full-Life Technologies, a fully integrated global radiotherapeutics company, reported an agreement to acquire New Jersey-based Focus-X Therapeutics, a company developing targeted radiopharmaceuticals to treat cancer based on proprietary peptide engineering technology (Press release, Full-Life Technologies, NOV 29, 2022, View Source [SID1234624543]). The acquisition expands Full-Life’s pipeline, including two compounds nearing clinical trials, provides a second innovative peptide focused discovery platform, and leverages its Radio Technology manufacturing and logistics platforms to advance compounds into clinical development.

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Under the terms of the acquisition, Focus-X shareholders are eligible to receive from Full-Life an upfront payment, potential development, regulatory and sales-based milestones of up to $245 million and royalties on any commercial sales. The acquisition is expected to close in the first quarter of 2023.

"The Focus-X acquisition perfectly leverages Full-Life’s radiotechnology and development platform by adding two development ready compounds, including a lead with initial human data, a robust pipeline and world class peptide discovery capabilities," said Lanny Sun, Co-founder, Chairman and CEO of Full-Life.

On November 29, 2022 Eli Lilly and Company (NYSE: LLY) reported that it will announce its financial guidance for 2023 on Tuesday, Dec. 13, 2022 (Press release, Eli Lilly, NOV 29, 2022, View Source [SID1234624542]). Lilly will also conduct a conference call on that day with the investment community and media to further detail the company’s financial guidance.

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The conference call will begin at 9 a.m. Eastern time. Investors, media and the general public can access a live webcast of the conference call through a link that will be posted on Lilly’s website at View Source A replay will also be available on the website following the conference call.

On November 29, 2022 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has granted CB-010 Regenerative Medicine Advanced Therapy (RMAT) designation for relapsed or refractory large B cell lymphoma (LBCL) and Fast Track designation for relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL) (Press release, Caribou Biosciences, NOV 29, 2022, View Source [SID1234624541]). CB-010, an allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout, is being evaluated in the company’s ongoing ANTLER Phase 1 clinical trial in patients with r/r B-NHL, which can enroll three LBCL subtypes: diffuse large B cell lymphoma (DLBCL), primary mediastinal large B cell lymphoma (PMBCL), and high-grade B cell lymphoma (HGBL). CB-010 is the first allogeneic anti-CD19 CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to improve the persistence of antitumor activity by limiting premature CAR-T cell exhaustion.

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"RMAT and Fast Track designations for CB-010 are important recognitions of the significant unmet patient need for an off-the-shelf cell therapy in the treatment of aggressive B-NHL," said Rachel Haurwitz, Ph.D., Caribou’s president and chief executive officer. "Through genome editing with our precision CRISPR chRDNA genome-editing technology, CB-010 has been designed with a PD-1 knockout strategy to improve the persistence of antitumor activity by limiting premature CAR-T cell exhaustion. In our ANTLER Phase 1 trial, 3 of 6 patients treated with CB-010 at dose level 1 maintained a durable complete response at 6 months. We are encouraged that CB-010 has demonstrated early potential as an off-the-shelf cell therapy that may meaningfully rival autologous cell therapies."

Encouraging safety data and antitumor activity for CB-010 at dose level 1 (40×106 CAR-T cells) have been reported from the ANTLER trial (www.cariboubio.com/technology/#pubs). As presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Congress, 6 of 6 patients (100%) achieved a complete response (CR) as best response after treatment with CB-010 at dose level 1 (40×106 CAR-T cells). Subsequently, at 6 months, 3 of 6 patients (50%) maintained a CR. Fifteen months is the longest CR maintained to date, observed in the first patient dosed in the ANTLER trial. CB-010 was generally well tolerated at dose level 1.

Both RMAT and Fast Track designations are dedicated programs designed to expedite the development and review processes for promising therapeutic candidates intended to address an unmet medical need in patients with serious conditions. These designations provide important benefits in the drug development process and are designed to facilitate and expedite development and regulatory review, including providing eligibility for Priority and Rolling Reviews, and Accelerated Approval, if relevant criteria are satisfied.

About CB-010

CB-010 is the lead product candidate from Caribou’s allogeneic CAR-T cell therapy platform and is being evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL) in the ongoing ANTLER Phase 1 trial. CB-010 is an allogeneic anti-CD19 CAR-T cell therapy engineered using Cas9 CRISPR hybrid RNA-DNA (chRDNA) technology to insert a CD19-specific CAR into the TRAC gene and knock out PD-1 to boost the persistence of antitumor activity. CB-010 is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout. CB-010 has been granted Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations. Additional information on the ANTLER trial can be found at View Source using identifier NCT04637763.

About Caribou’s Novel Next-Generation CRISPR Platform
CRISPR genome editing uses easily designed, modular biological tools to make DNA changes in living cells. There are two basic components of Class 2 CRISPR systems: the nuclease protein that cuts DNA and the RNA molecule(s) that guide the nuclease to generate a site-specific, double-stranded break, leading to an edit at the targeted genomic site. CRISPR systems are capable of editing unintended genomic sites, known as off-target editing, which may lead to harmful effects on cellular function and phenotype. In response to this challenge, Caribou has developed CRISPR hybrid RNA-DNA guides (chRDNAs; pronounced "chardonnays") that direct substantially more precise genome editing compared to all-RNA guides. Caribou is deploying the power of its Cas12a chRDNA technology to carry out multiple edits at high efficiency, including multiplex gene insertions, to develop CRISPR-edited therapies.

On November 29, 2022 Ribon Therapeutics, a clinical stage biotechnology company developing therapeutics targeting stress support pathways, reported that it entered into an agreement on the acquisition of its CD38 program with Boehringer Ingelheim (Press release, Ribon Therapeutics, NOV 29, 2022, View Source [SID1234624540]). This includes a small molecule inhibitor designed to modulate intra- and extracellular CD38 activity, potentially restoring immune function in various diseases, as well as corresponding patents and other proprietary information. Boehringer Ingelheim aims to develop novel therapies based on Ribon’s CD38 program to transform the lives of patients with immunological and fibrotic diseases.

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"We are pleased to enter this agreement with Boehringer Ingelheim as they build upon the pioneering work with our BEACON+ platform to potentially deliver first-in-class treatments to significantly improve outcomes for patients with diseases where CD38 activity is implicated," said Prakash Raman, Ph.D., President and Chief Executive Officer, Ribon Therapeutics. "Additionally, we believe this agreement, along with our ongoing clinical trials evaluating RBN-2397 and RBN-3143, further validates our approach and ability to discover and develop potentially meaningful treatment options targeting NAD+-utilizing enzymes using the BEACON+ platform."

Ribon has developed this program from target and lead discovery through lead optimization using its proprietary BEACON+ platform. Under the terms of the agreement, Ribon will receive an undisclosed upfront payment and is eligible to receive future payments related to preclinical, clinical, regulatory and commercial milestones.

On November 29, 2022 Candel Therapeutics, Inc. ("Candel" or "the Company") (Nasdaq: CADL), a clinical stage biopharmaceutical company developing novel viral immunotherapies, reported it will host a virtual Research and Development (R&D) Day from 11:00 am – 1:30 pm ET on Tuesday, December 6, 2022 (Press release, Candel Therapeutics, NOV 29, 2022, View Source [SID1234624539]).

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Candel’s first R&D Day will include presentations from its executive leadership, clinical investigators, scientific advisors, and key collaborators. The event will provide an extensive overview of the Company’s viral immunotherapy approach and oncology-focused pipeline, with new data being presented from its phase 2 clinical trial of CAN-2409 in combination with anti-PD-1 agents in patients with stage III/IV non-small cell lung cancer (NSCLC). The event will conclude with an interactive Q&A session. Click here to register for the event.

The event will include the following presenters:

Introduction to Candel Therapeutics

Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer, Candel Therapeutics

Intratumor viral immunotherapy: a new approach to induce systemic anti-tumor immunity

James P. Allison, PhD, Regental Professor and Chair of the Department of Immunology, MD Anderson Cancer Center and Director, Parker Institute for Cancer Research

Clinical perspective on viral immunotherapy

Padmanee Sharma, MD, PhD, Professor of Genitourinary Medical Oncology and Immunology, MD Anderson Cancer Center

Phase 2 clinical trial of CAN-2409 treatment in NSCLC

Charu Aggarwal, MD, MPH, Associate Professor for Lung Cancer Excellence, Perelman School of Medicine, University of Pennsylvania

Daniel H. Sterman, MD, Professor and Director, Pulmonary, Critical Care and Sleep Medicine, NYU Langone Health

Roy Herbst, MD, PhD, Ensign Professor of Medicine, Professor of Pharmacology and Chief of Medical Oncology, Yale Cancer Center

Phase 1 clinical trial of CAN-2409 combined with nivolumab and standard of care in first-line treatment with high-grade glioma

Patrick Y. Wen, MD, Director, Center for Neuro-Oncology, Dana-Farber Cancer Institute and Professor, Neurology, Harvard Medical School

Phase 1 clinical trial of CAN-3110 in recurrent high-grade glioma

E. Antonio Chiocca, MD, PhD, Chair, Department of Neurosurgery, Brigham and Women’s Hospital and Professor, Harvard Medical School

The enLIGHTEN Discovery Platform

Francesca Barone, MD, PhD, Chief Scientific Officer, Candel Therapeutics

UPenn – Candel discovery partnership: Combination therapy to overcome CAR-T resistance in solid tumors

Carl H. June, MD, Richard W. Vague Professor in Immunotherapy and Director, Center for Cellular Immunotherapies and Parker Institute for Cancer Therapy, Perelman School of Medicine, University of Pennsylvania

Neil C. Sheppard, DPhil, Adjunct Associate Professor of Pathology and Laboratory Medicine, Head of the T Cell Engineering Lab, and Director for Research Technologies and Innovation, Center for Cellular Immunotherapies, Perelman School of Medicine, University of Pennsylvania

Interactive Q&A

Registration for this virtual event and access to the live webcast and subsequent replay will be accessible under "Events and Presentations" on the Investors page of the Company’s website at View Source or by clicking here.